Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT02146170

Conditions

Non-Small Cell Lung Cancer

Small Cell Lung Cancer

Extrapulmonary Small Cell Cancer

Pulmonary Neuroendocrine Tumors

Thymic Epithelial Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

\- Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it.

Objective:

\- To collect tissue samples for use in the study of lung cancers.

Eligibility:

\- Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.

Design:

  • Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks.
  • Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy.
  • Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine that takes pictures of the body.
  • After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.

Conditions

Non-Small Cell Lung Cancer

Small Cell Lung Cancer

Extrapulmonary Small Cell Cancer

Pulmonary Neuroendocrine Tumors

Thymic Epithelial Tumors

Study ID

NCT02146170

Start date

May 28, 2014

Status verified date

Aug 26, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • Individuals with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET.
  • Individuals consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a malignancy of the above histologies, pending further tissue acquisition and/or pathology review.
  • Age greater than or equal to18 years. Children are excluded from the study, as the above thoracic malignancies are rare in this population.
  • Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

  • Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
  • Active concomitant medical or psychological illnesses that may increase the risk to the subject, at the discretion of the Principal Investigator.
  • Known HIV-positive individuals not on combination antiretroviral therapy are ineligible.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Single group

Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET

Primary outcome measure

  • Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Shannon G Swift, R.N.

(240) 858-3157shannon.swift@nih.gov

Arun Rajan, M.D.

(240) 760-6236rajana@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 28, 2026

Last verified

Aug 26, 2026

Keywords

  • Sample Acquisition
  • Genetic and Epigenetic Alterations
  • Mig6 Expression
  • Proteomic Analysis
  • Genomic Analysis
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-28.